midterm

Question 1

3 guiding principles of belmont report

Answer 1

1. Respect for persons - informed consent and protection of vulnerable populations
2. beneficence - do not harm. maximize benefits and minimize risk
3. Justice - fair and equal treatment in bearing burdens and receiving benefits of research. Include diverse populations

Question 2

persons with diminished autonomy entitled to protection

Answer 2

children
mentally disabled
prisoners

Question 3

informed consent process (respect for persons)

Answer 3

gives enough info to decide wether or not to participate
gives comprehension through understandable language and answering question
voluntariness free of coercion or influence

Question 4

IRB must consider

Answer 4

risk to subjects
benefits to subjects
importance of knowledge to be gained
informed consent process

Question 5

IRB must report to federal agencies what?

Answer 5

• Injuries to human subjects or unanticipated problems

* Serious or continuing noncompliance with regulations or IRB requirements

Question 6

what is consent?

Answer 6

consent must be informed, understood, and voluntary

Question 7

Office for Human Research Protection (OHRP)

Answer 7

oversees Assurances –US institutions as well as international institutions receiving DHHS funds for research
federally funded research cannot be conducted until assurance is re-instated
has authority to terminate or suspend institution’s research

Question 8

Federal-Wide Assurance (FWA) aka assurance of compliance is needed before?

Answer 8

a federal grant or contract is awarded to institutions

FWA makes institution agree to federal regulations

Question 9

Federal-Wide Assurance (FWA) aka assurance of compliance is needed before?

Answer 9

a federal grant or contract is awarded to institutions

FWA makes institutions agree to apply federal regulations

Question 10

IRB acts as?

Answer 10

federal government in conducting duty of supervising research

Question 11

IRB acts as?

Answer 11

federal government in conducting duty of supervising research

Question 12

research study with prisoners must be?

Answer 12

applicable to health concerns in prison setting like

hepatitis

Question 13

good clinical practice

Answer 13

protect participants

Question 14

good clinical practice branches?

Answer 14

FDA 21 CFR
OHRP (DHHS) 45 CFR 46
International council for harmonisation (ICH)

Question 15

state and local regulations general rule

Answer 15

federal laws must be followed if stricter than state regulations
whichever is stricter must be followed

Question 16

21 CFR FDA regulated research

Answer 16

regulates:
financial disclosure for drug development
IRB

Question 17

how long are study records maintained?

Answer 17

minimum of 2 years after FDA approval or discontinuation

3 yrs after completion of study for DHHS

Question 18

ICH

Answer 18

international board that sets standards for the pharmaceutical industry

Question 19

confidentiality certificate

Answer 19

protects information about subjects against a legal order to discover data
given by NIH and IRB tells you to get it

Question 20

levels of IRB protocol review

Answer 20

exempt - review protocols that are minimal risk. usually retrospective. IRB not required if subject cannot be identified. ONLY IRB decides if exemption applies or not
expedited - reviews protocols that are minimal risk and can be retrospective or prospective. having 3 members of IRB can give you permission instead of the full board. may not be allowed if subject ID poses risk of privacy protection. consent can be waived
full board - for research with greater than minimal risk

Question 21

levels of IRB review

Answer 21

exempt - reviews protocol that are minimal risk. usually retrospective. IRB not required if subject cannot be identified. ONLY IRB decides if exemption applies or not
expedited - review protocol that are minimal risk and can be retrospective or prospective. having 3 members of IRB can give you permission instead of the full board. may not be allowed if subject ID poses risk of privacy protection. consent can be waived
full board - for research with greater than minimal risk

Question 22

informed consent review lets subjects know about?

Answer 22

risks
purpose
benefits
disclosure
confidentiality
compensation
answers to questions
voluntariness

Question 23

protocol deviations

Answer 23

decrease credibility of data and affect licensing of drug

Question 24

adverse event

Answer 24

any deterioration in health status wether or not associated with drug must be reported
like hospitalization, a finding in PE, symptom,

Question 25

adverse drug rxn

Answer 25

due to a drug must also be reported

Question 26

unexpected adverse event

Answer 26

new event not listed on risk information in protocol or investigator brochure.

Question 27

serious adverse events must be reported to IRB within?

Answer 27

24 hours

Question 28

final rule

Answer 28

no research misconduct by fabrication, falsification or other practices that deviate from scientific community
intentional flaw

Question 29

what are the simple concepts that drive decision making when implementing clinical trials?

Answer 29

subject welfare
data validity
control of investigational product

Question 30

Good Clinical Practice in US

FDA 21 CFR

Answer 30

Electronic documents informed consent

Financial disclosure

IRBs

IND (investigational new drug) and NDA (new drug application)

Biologics

devices

Question 31

Good Clinical Practice in US

OHRP (DHHS) 45 CFR 46

Answer 31

IRBs and informed consent

Protection of pregnant women, fetuses, neonates, prisoners, children

Registration of IRB

Question 32

Good Clinical Practice in US

ICH

Answer 32

International board that sets standards for pharmaceutical industry

Question 33

Expected adverse event vs unexpected adverse event

Answer 33

expected adverse event - adverse experience/ risk information in sponsor protocol or investigator brochure
unexpected adverse event - any adverse experience not constistent with risk info described in sponsor protocol or investigator brochure